Clinical Research Coord III - Pediatric Child Health Research Institute

Clinical Research Coordinator III

Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

• Acts as a clinical trial coordinator assisting PI with subject identification recruitment and enrollment. Takes primary responsibility for creation and maintenance of regulatory documents including initial IRB submissions continuing review submissions and FDA and sponsor regulatory documents. Schedule perform and or coordinate all study procedures / visits across all disciplines. Ensure that GCP is maintained throughout the length of the study. Host / prepare for external and internal audits (sponsor FDA NIH IRB etc.) Responsible for the protocol specific training of research and clinical staff involved in the study. Development of protocol specific case report forms as needed. Maintain and coordinate all aspects of complex study conduct including data source documentation adverse event reporting and communication with the IRB. Reviews and verifies that all trial-related charges are billed to the project. Works with administrative and clinical offices on obtaining invoices for trial services and verifying accuracy of received invoices. Trains trial coordinators develops policies and best practices.

• Coordinates activities related to development and operation of the various clinical trials/research in gene therapy and grant proposals. Such activities may include: coordination of collaborative research efforts among members of the program; organization and writing of protocols and grants coordination with UFs Institutional Review Board the Western Institutional Review Board IACUC General Clinical Research Center as well as the Division of Sponsored Research. Position will assist the Program Director in evaluating program operation based on criteria of efficiency and effectiveness and will modify suggest and/or implement policies and procedures as necessary.

• Performs outreach duties for the program including but not limited to: preparing and giving presentations about the program or portions of the program for UF audiences; preparing and giving presentations about the program or portions of the program to the general public including community groups school groups scientific meetings and potential financial investors/donors; assist in the design of program related print promotional and educational materials for public distribution; design and prepares a newsletter for distribution to program members; responds to inquiries from the program website as opportunities arise.

$60000

Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

Masters degree in an appropriate area of specialization and six years of appropriate experience; or a bachelors degree in an appropriate area of specialization and eight years of appropriate experience or an equivalent combination of education and experience.

Experience working with pediatric and adult patient population

Experience working with patients diagnosed with rare diseases

Understanding of inherited muscle diseases which lead to heart and skeletal muscle dysfunction

Knowledge of UF Institutional Review Board and Western Institutional Review Board policies and procedure

Prior experience with direct patient contact

Proficiency in all Microsoft Office applications

Ability to communicate effectively both verbally and in writing

Excellent interpersonal skills; ability to work independently

Solve problems and make appropriate decisions

Understanding of regulatory compliance as it relates to conducting the Study at University of Florida

To be considered for this position please upload your cover letter or letter of interest resume and a list of professional references.

Monday through Friday 8:00am to 5:00pm. Nights & weekends as needed for on-going research.

The University of Florida is committed to non-discrimination with respect to race creed color religion age disability sex sexual orientation gender identity and expression marital status national origin political opinions or affiliations genetic information and veteran status in all aspects of employment including recruitment hiring promotions transfers discipline terminations wage and salary administration benefits and training.

This is a time-limited position. Application must be submitted by 11:55 p.m. (ET) of the posting end date

Application must be submitted by 11:55 p.m. (ET) of the posting end date.